Improving Asthma Communication in Minority Families

The purpose of this study is to determine if teaching children with asthma how to talk to their doctor about controlling their asthma including symptom frequency in an asthma diary and medication use techniques, will result in less symptom and missed school days, fewer emergency room visits and reduce the cost of asthma health care.

Study Overview

Detailed Description

Children with persistent asthma are often not receiving regular preventive asthma care despite experiencing frequent asthma symptoms. When linked to timely and appropriate asthma medication use, good physician-parent-child communication is associated with a decrease in asthma morbidity and mortality. Removing obstacles to preventive asthma care and improving communication between the parent-children and PCP are two necessary prerequisites to improving asthma outcomes in low-income minority children.

We, the researchers at Johns Hopkins University, hypothesize that a culturally-tailored parent and child asthma communication intervention (ACI) designed to teach parent and child communication skills for use with their health care provider regarding asthma symptom severity, medication use, personal goal of treatment and quality of life issues will significantly reduce emergency room utilization for asthma care. We propose to compare this parent/child asthma communication intervention (ACI) to a developed standard asthma education intervention (SAE) designed to increase basic asthma self-management.

This study will advance nursing science by improving asthma self-management for school age children, who may be self-administering their asthma medications, yet not participate in receiving information or making their own medical decisions regarding their asthma. The proposed study is targeted at low-income minority school-aged children with evidence of poorly controlled, high-risk asthma. If successful, this intervention could have significant practical applications as a component of asthma nurse-case management, to practice currently being employed by many managed care groups across the country as an intervention for their high-risk/high ED use asthma patients. Because of the high prevalence and enormous health impact of asthma and the disproportionate asthma burden experienced by minority children, the outcome of the proposed study will have significant pediatric nursing applicability.

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 6-12 years
  • Physician diagnosis of asthma
  • Reside in metropolitan Baltimore
  • English speaking
  • Able to read 80% of parent educational brochure in English
  • Emergency Department (ED) visit within the past 12 months and can identify a primary care provider
  • No other co-morbid pulmonary disease

Exclusion Criteria:

  • Enrolled in another asthma study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Active Comparator: 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduce the cost of asthma health care.
Time Frame: 18 Months
18 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Fewer emergency room visits
Time Frame: 18 Months
18 Months
Less symptoms
Time Frame: 18 Months
18 Months
Fewer missed school days
Time Frame: 18 Months
18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arlene Butz, SCD,MSN,BSN, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

August 19, 2005

First Submitted That Met QC Criteria

August 19, 2005

First Posted (Estimate)

August 23, 2005

Study Record Updates

Last Update Posted (Estimate)

July 17, 2008

Last Update Submitted That Met QC Criteria

July 16, 2008

Last Verified

July 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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